Trial Outcomes & Findings for Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas (NCT NCT05479123)

Results Overview

This item assesses the number of times the child wakes during the night, as reported by the caregiver response to the question, "How many times does your child usually wake during the night?" from a single item of the Brief Infant Sleep Questionnaire (BISQ).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

6 months from baseline

Results posted on

2026-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Ter in Die (TID)Three Times a Day Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Overall Study STARTED	18	18	16
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	18	18	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ter in Die (TID)Three Times a Day n=18 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day n=18 Participants Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control n=16 Participants Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).	Total n=52 Participants Total of all reporting groups
Age, Continuous	19.3 months STANDARD_DEVIATION 6.9 • n=41 Participants	16.1 months STANDARD_DEVIATION 7.5 • n=39 Participants	17.8 months STANDARD_DEVIATION 6.9 • n=80 Participants	17.7 months STANDARD_DEVIATION 7.1 • n=296 Participants
Sex: Female, Male Female	14 Participants n=41 Participants	14 Participants n=39 Participants	9 Participants n=80 Participants	37 Participants n=296 Participants
Sex: Female, Male Male	4 Participants n=41 Participants	4 Participants n=39 Participants	7 Participants n=80 Participants	15 Participants n=296 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=41 Participants	5 Participants n=39 Participants	5 Participants n=80 Participants	19 Participants n=296 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=41 Participants	10 Participants n=39 Participants	8 Participants n=80 Participants	27 Participants n=296 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants	3 Participants n=39 Participants	3 Participants n=80 Participants	6 Participants n=296 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants	0 Participants n=39 Participants	0 Participants n=80 Participants	0 Participants n=296 Participants
Race (NIH/OMB) Asian	1 Participants n=41 Participants	0 Participants n=39 Participants	0 Participants n=80 Participants	1 Participants n=296 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants	0 Participants n=39 Participants	0 Participants n=80 Participants	0 Participants n=296 Participants
Race (NIH/OMB) Black or African American	1 Participants n=41 Participants	2 Participants n=39 Participants	1 Participants n=80 Participants	4 Participants n=296 Participants
Race (NIH/OMB) White	4 Participants n=41 Participants	9 Participants n=39 Participants	4 Participants n=80 Participants	17 Participants n=296 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants	0 Participants n=39 Participants	0 Participants n=80 Participants	0 Participants n=296 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=41 Participants	7 Participants n=39 Participants	11 Participants n=80 Participants	30 Participants n=296 Participants
Region of Enrollment United States	18 participants n=41 Participants	18 participants n=39 Participants	16 participants n=80 Participants	52 participants n=296 Participants

PRIMARY outcome

Timeframe: 6 months from baseline

Population: Data were only collected and analyzed for participants who completed the question at this timepoint. 0 participants completed this question in the bis in die (BID)twice a day arm and the control arm, therefore no data were collected or analyzed for these arms and it will not be collected in the future.

This item assesses the number of times the child wakes during the night, as reported by the caregiver response to the question, "How many times does your child usually wake during the night?" from a single item of the Brief Infant Sleep Questionnaire (BISQ).

Outcome measures

Outcome measures
Measure	Ter in Die (TID)Three Times a Day n=1 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Number of Sleep Awakenings Per Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)	2 sleep awakenings per night	—	—

SECONDARY outcome

Timeframe: 3 months from baseline

Population: Data were only collected and analyzed for participants who completed the question at this timepoint.

This item assesses the total amount of time the child is usually awake during the night, as reported by the caregiver response, "How much total time during the night is your child usually awake (between when your child goes to bed and wakes for the day)?"Results are reported in minutes.

Outcome measures

Outcome measures
Measure	Ter in Die (TID)Three Times a Day n=8 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day n=6 Participants Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control n=1 Participants Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)	40.6 minutes Standard Deviation 69.6	35 minutes Standard Deviation 22.6	30 minutes

SECONDARY outcome

Timeframe: 6 months from baseline

Population: Data were only collected and analyzed for participants who completed the question at this timepoint. 0 participants completed this question in the control arm, therefore no data were collected or analyzed for this arm and it will not be collected in the future.

This item assesses the total amount of time the child is usually awake during the night, as reported by the caregiver response to the question "How much total time during the night is your child usually awake (between when your child goes to bed and wakes for the day)?"Results are reported in minutes.

Outcome measures

Outcome measures
Measure	Ter in Die (TID)Three Times a Day n=3 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day n=1 Participants Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)	60 minutes Standard Deviation 34.6	0 minutes Standard Deviation 0	—

SECONDARY outcome

Timeframe: 9 months from baseline

Population: Data were only collected and analyzed for participants who completed the questionnaire at this timepoint.

This item assesses the total amount of time the child is usually awake during the night, as reported by the caregiver response to the question "How much total time during the night is your child usually awake (between when your child goes to bed and wakes for the day)?"Results are reported in minutes.

Outcome measures

Outcome measures
Measure	Ter in Die (TID)Three Times a Day n=3 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day n=2 Participants Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control n=2 Participants Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)	11.7 minutes Standard Deviation 16.1	12.5 minutes Standard Deviation 3.5	7.5 minutes Standard Deviation 3.5

SECONDARY outcome

Timeframe: 12 months from baseline

Population: Data were only collected and analyzed for participants who completed the question at this timepoint. 0 participants from the bis in die (BID) twice a day arm and the control arm followed up at 12 months from baseline, therefore no data were analyzed or collected for these arms and they will not be collected in the future.

This item assesses the total amount of time the child is usually awake during the night, as reported by the caregiver response to the question "How much total time during the night is your child usually awake (between when your child goes to bed and wakes for the day)?"Results are reported in minutes.

Outcome measures

Outcome measures
Measure	Ter in Die (TID)Three Times a Day n=2 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Total Amount of Time Subject is Awake at Night as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)	12.5 minutes Standard Deviation 3.5	—	—

SECONDARY outcome

Timeframe: 15 months from baseline

Population: This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 15 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure.

This item assesses the total amount of time the child is usually awake during the night, as reported by the caregiver response to the question "How much total time during the night is your child usually awake (between when your child goes to bed and wakes for the day)?"Results are reported in minutes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months from baseline

Population: This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 18 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure.

This item assesses the total amount of time the child is usually awake during the night, as reported by the caregiver response to the question "How much total time during the night is your child usually awake (between when your child goes to bed and wakes for the day)?"Results are reported in minutes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months from baseline

Population: Data were only collected and analyzed for participants who completed the questionnaire at this timepoint.

The one item in the brief infant sleep questionnaire assesses difficulty falling asleep. The total score ranges from 1 to 5, a higher score indicates greater difficulty in falling asleep.

Outcome measures

Outcome measures
Measure	Ter in Die (TID)Three Times a Day n=6 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day n=4 Participants Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control n=2 Participants Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)	2 score on a scale Interval 2.0 to 2.75	1.5 score on a scale Interval 1.0 to 2.25	2 score on a scale Interval 1.5 to 2.5

SECONDARY outcome

Timeframe: 6 months from baseline

Population: Data were only collected and analyzed for participants who completed the questionnaire at this timepoint. 0 participants from the control arm followed up at 6 months from baseline, therefore no data were analyzed or collected for this arm and they will not be collected in the future.

The one item in the brief infant sleep questionnaire assesses difficulty falling asleep. The total score ranges from 1 to 5, a higher score indicates greater difficulty in falling asleep.

Outcome measures

Outcome measures
Measure	Ter in Die (TID)Three Times a Day n=3 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day n=1 Participants Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)	2 score on a scale Interval 2.0 to 2.5	1 score on a scale Interval 1.0 to 1.0	—

SECONDARY outcome

Timeframe: 9 months from baseline

Population: Data were only collected and analyzed for participants who completed the questionnaire at this timepoint.

The one item in the brief infant sleep questionnaire assesses difficulty falling asleep. The total score ranges from 1 to 5, a higher score indicates greater difficulty in falling asleep.

Outcome measures

Outcome measures
Measure	Ter in Die (TID)Three Times a Day n=2 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day n=2 Participants Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control n=3 Participants Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)	1.5 score on a scale Interval 1.25 to 1.75	2 score on a scale Interval 1.5 to 2.5	2 score on a scale Interval 2.0 to 2.5

SECONDARY outcome

Timeframe: 12 months from baseline

Population: Data were only collected and analyzed for participants who completed the questionnaire at this timepoint. 0 participants from the bis in die (BID) twice a day arm and the control arm followed up at 12 months from baseline, therefore no data were analyzed or collected for these arms and they will not be collected in the future.

The one item in the brief infant sleep questionnaire assesses difficulty falling asleep. The total score ranges from 1 to 5, a higher score indicates greater difficulty in falling asleep.

Outcome measures

Outcome measures
Measure	Ter in Die (TID)Three Times a Day n=2 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Difficulty Falling Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)	2.5 score on a scale Interval 2.25 to 2.75	—	—

SECONDARY outcome

Timeframe: 15 months from baseline

Population: This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 15 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure.

The one item in the brief infant sleep questionnaire assesses difficulty falling asleep. The total score ranges from 1 to 5, a higher score indicates greater difficulty in falling asleep.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months from baseline

Population: This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 18 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure.

The one item in the brief infant sleep questionnaire assesses difficulty falling asleep. The total score ranges from 1 to 5, a higher score indicates greater difficulty in falling asleep.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months from baseline

Population: Data were only collected and analyzed for participants who completed the questionnaire at this timepoint.

This item assesses the total amount of time it takes the child to fall asleep, as reported by the caregiver response to, "How long does it usually take your child to fall asleep?" Results are reported in minutes.

Outcome measures

Outcome measures
Measure	Ter in Die (TID)Three Times a Day n=6 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day n=5 Participants Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control n=2 Participants Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Amount of Time it Takes for Subject to Fall Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)	20 minutes Standard Deviation 10	21 minutes Standard Deviation 8	22.5 minutes Standard Deviation 7.5

SECONDARY outcome

Timeframe: 6 months from baseline

Population: Data were only collected and analyzed for participants who completed the questionnaire at this timepoint. 0 participants from the control arm followed up at 6 months from baseline, therefore no data were analyzed or collected for this arms and they will not be collected in the future.

This item assesses the total amount of time it takes the child to fall asleep, as reported by the caregiver response to, "How long does it usually take your child to fall asleep?" Results are reported in minutes.

Outcome measures

Outcome measures
Measure	Ter in Die (TID)Three Times a Day n=3 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day n=1 Participants Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Amount of Time it Takes for Subject to Fall Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)	23.3 minutes Standard Deviation 17	5 minutes	—

SECONDARY outcome

Timeframe: 9 months from baseline

Population: Data were only collected and analyzed for participants who completed the questionnaire at this timepoint.

This item assesses the total amount of time it takes the child to fall asleep, as reported by the caregiver response to, "How long does it usually take your child to fall asleep?" Results are reported in minutes.

Outcome measures

Outcome measures
Measure	Ter in Die (TID)Three Times a Day n=2 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day n=2 Participants Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control n=3 Participants Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Amount of Time it Takes for Subject to Fall Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)	25 minutes Standard Deviation 5	17.5 minutes Standard Deviation 12.5	26.7 minutes Standard Deviation 16.5

SECONDARY outcome

Timeframe: 12 months from baseline

Population: Data were only collected and analyzed for participants who completed the question at this timepoint. 0 participants from the bis in die (BID) twice a day arm and the control arm followed up at 12 months from baseline, therefore no data were analyzed or collected for these arms and they will not be collected in the future.

This item assesses the total amount of time it takes the child to fall asleep, as reported by the caregiver response to, "How long does it usually take your child to fall asleep?" Results are reported in minutes.

Outcome measures

Outcome measures
Measure	Ter in Die (TID)Three Times a Day n=2 Participants Propranolol three times a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided TID Week 2: 1 mg/kg/day divided TID Week 3: 2 mg/kg/day divided TID. Patients will stay on this dosage until their 3 month follow up visit.	Bis in Die (BID)Twice a Day Propranolol twice a day: Patients with larger (\>2cm) or multiple (\>1) hemangiomas in this arm will get propranolol in the following regimen: Week 1: 0.5 mg/kg/day divided BID Week 2: 1 mg/kg/day divided BID Week 3: 2 mg/kg/day divided BID. Patients will stay on this dosage until their 3 month follow up visit.	Control Timolol: Patients with a small (\<2cm) isolated infantile hemangioma are prescribed timolol 0.5% ophthalmic drops, a topical beta-blocker(1 drop BID directly onto the hemangioma).
Amount of Time it Takes for Subject to Fall Asleep as Assessed by One-Item in the Brief Infant Sleep Questionnaire(BISQ)	37.5 minutes Standard Deviation 22.5	—	—

SECONDARY outcome

Timeframe: 15 months from baseline

Population: This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 15 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure.

This item assesses the total amount of time it takes the child to fall asleep, as reported by the caregiver response to, "How long does it usually take your child to fall asleep?" Results are reported in minutes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months from baseline

Population: This outcome measure was pre-specified in the protocol; however, no data were collected for this measure because zero participants completed the 18 month follow up assessment. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure.

This item assesses the total amount of time it takes the child to fall asleep, as reported by the caregiver response to, "How long does it usually take your child to fall asleep?" Results are reported in minutes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months from baseline

Population: Data were only collected and analyzed for participants who completed the question at this timepoint.